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Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

NCT02418650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-06-23

No results posted yet for this study

Summary

A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

ODM-201 300 mg tablet

DRUG

intravenous14C-ODM-201

DRUG

300 mg 14C-ODM-201 oral solution

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Philip Evans, MB ChB MRCS · Quotient Clinical

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United Kingdom

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02418650 on ClinicalTrials.gov